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Citius Pharmaceuticals, Inc. (CTXR)·Q3 2024 Earnings Summary

Executive Summary

  • Pre-revenue quarter with GAAP EPS of $-0.06 and net loss of $10.6M; operating loss rose on higher G&A and stock-based compensation tied to commercialization preparations .
  • FDA approved LYMPHIR (denileukin diftitox-cxdl) for r/r CTCL; launch targeted within five months, establishing the first FDA-approved product in the portfolio and shifting focus to commercial execution .
  • Completed spin-off/merger to form Citius Oncology (CTOR), with CTXR retaining ~90% ownership; intended partial distribution of CTOR shares to CTXR holders noted as a potential future catalyst .
  • Cash runway extended to December 2024 following a $15M April financing; cash balance ended Q3 at $17.9M, with management evaluating non-dilutive capital options .

What Went Well and What Went Wrong

What Went Well

  • FDA approval of LYMPHIR, the only IL-2 receptor-targeted systemic therapy for r/r CTCL; management: “LYMPHIR offers new hope… expected to expand the CTCL treatment landscape and grow the overall market” .
  • Mino-Lok Phase 3 trial achieved primary and secondary endpoints; management emphasized “highly statistically significant topline results” and plans for a Type B FDA meeting .
  • Corporate actions to enable commercialization: completed CTOR spin-off to broaden investor access; onboarded National Sales Director to build the LYMPHIR sales organization .

What Went Wrong

  • Continued operating losses with higher G&A driven by pre-launch and market research; G&A up to $4.8M (+$1.0M YoY), stock-based compensation to $3.1M (+$1.9M YoY) .
  • Research pipeline still requires funding and regulatory steps; management reiterated need to secure additional capital beyond December 2024 .
  • No revenue recognized, reflecting pre-commercial status; net loss increased $2.1M YoY, primarily due to higher G&A and SBC .

Financial Results

Quarterly P&L and KPIs (oldest → newest)

MetricQ1 2024Q2 2024Q3 2024
Revenues ($USD)$0 $0 $0
R&D Expense ($USD)$2,621,910 $3,605,898 $2,763,865
G&A Expense ($USD)$3,660,728 $4,285,911 $4,808,551
Stock-based Comp (G&A) ($USD)$3,058,185 $3,078,392 $3,061,763
Total Operating Expenses ($USD)$9,340,823 $10,970,201 $10,634,179
Operating Loss ($USD)$(9,340,823) $(10,970,201) $(10,634,179)
Interest & Other Income ($USD)$253,638 $2,570,047 $204,843
Net Loss ($USD)$(9,231,185) $(8,544,154) $(10,573,336)
Net Loss Applicable to Shareholders ($USD)$(9,231,185) $(8,544,154) $(10,894,895)
GAAP EPS ($)$(0.06) $(0.05) $(0.06)
Weighted Avg Shares (Basic & Diluted)158,955,935 159,072,239 173,856,960
Cash & Equivalents ($USD)$20,345,618 $12,559,607 $17,911,192
Shares Outstanding (End of Period)158,966,576 159,094,781 158,857,798

Year-over-Year Q3 Comparison

MetricQ3 2023Q3 2024
R&D Expense ($USD)$3,764,675 $2,763,865
G&A Expense ($USD)$3,733,326 $4,808,551
Stock-based Comp (G&A) ($USD)$1,174,111 $3,061,763
Operating Loss ($USD)$(8,672,112) $(10,634,179)
Net Loss ($USD)$(8,479,332) $(10,573,336)
GAAP EPS ($)$(0.06) $(0.06)

Segment/KPIs

KPIQ1 2024Q2 2024Q3 2024
Runway commentThrough Aug 2024 Through Dec 2024 (post-raise) Through Dec 2024
Financing updateNone disclosed $15M gross offering (Apr 30) $15M gross offering extended runway
Regulatory milestonesBLA resubmitted (LYMPHIR) BLA accepted; PDUFA Aug 13 FDA approval Aug 8; launch ≤5 months
Strategic actionsTENK merger agreement Spin-off progressing CTOR formed; CTXR ~90% ownership

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2024Sufficient through August 2024 Sufficient through December 2024 after $15M raise Raised/Extended
LYMPHIR timing2H 2024PDUFA target date Aug 13, 2024 FDA approved; U.S. launch within next five months Transitioned to commercial launch timing
Mino-Lok2024Topline results anticipated in 2Q 2024 Primary/secondary endpoints achieved; Type B FDA meeting planned Advanced to post-Phase 3 next steps
Halo-Lido2024End of Phase 2b FDA meeting scheduled 2Q 2024 Continued FDA engagement on next steps Maintained progression narrative

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2024)Trend
LYMPHIR regulatory/commercializationBLA resubmitted (Q1); BLA accepted, Aug 13 PDUFA (Q2) FDA approval, launch ≤5 months De-risked; execution focus
Mino-Lok clinical pathEnrollment complete; topline results expected (Q1/Q2) Endpoints met; Type B meeting planning Progressing toward regulatory dialogue
Capital/cash runwayRunway to Aug 2024 (Q1); $15M raise extends to Dec 2024 (Q2) Runway to Dec 2024; exploring non-dilutive capital Extended; seeking additional sources
Corporate structureTENK merger agreement (Q1) Spin-off progressing (Q2) CTOR formed; CTXR ~90% ownership
Commercial buildPre-launch activities (Q2) National Sales Director onboarded Scaling for launch

Management Commentary

  • “LYMPHIR… was approved by the FDA… This is the first FDA-approved product in our portfolio and paves the way for Citius Oncology to transition from a development stage company to a commercial biopharmaceutical organization.” — Leonard Mazur .
  • “The completion of our Phase 3 Pivotal Trial for Mino-Lok… further underscores our commitment to developing life-saving treatments… we secured $15 million in additional funding to extend our runway… and completed the spin-off of this asset into our… publicly traded oncology company.” — Leonard Mazur .
  • “The BLA submission for LYMPHIR… was accepted by the FDA… In anticipation of potential approval, we continue to align the organization for a successful launch.” — Leonard Mazur (Q2) .

Q&A Highlights

  • Management scheduled an investor call on August 13, 2024 at 8:30 a.m. ET with a Q&A session to discuss recent developments; replay available for 90 days .

Estimates Context

  • S&P Global consensus estimates for Q3 2024 were unavailable at the time of analysis; comparisons to consensus cannot be anchored to S&P Global in this report.
  • Third-party aggregator indicated EPS estimate of $-0.06 and reported actual EPS of $-0.06 (met), with no revenue reported; treat non-S&P sources as indicative only .

Key Takeaways for Investors

  • FDA approval of LYMPHIR and expected launch within five months are the primary near-term catalysts; commercial execution is now the core driver .
  • Spin-off into CTOR creates a focused oncology vehicle while CTXR retains ~90% ownership, with intent to distribute a portion of CTOR shares to CTXR holders potentially unlocking value .
  • Expense mix shift reflects commercialization prep: G&A up YoY; R&D down post-trial completion; expect continued investment in launch infrastructure and medical affairs .
  • Liquidity improved with April financing; runway to December 2024, but management signaled need for additional capital beyond that horizon (watch for non-dilutive funding moves) .
  • Mino-Lok de-risked with positive Phase 3 endpoints; regulatory next steps (Type B meeting) could define timelines and potential partnering/monetization path .
  • With zero revenue recognized in Q3, initial LYMPHIR uptake, payer coverage, and physician adoption will be critical to trajectory in FY2025; monitor launch timing and early demand indicators .
  • Stock narrative hinges on execution and funding cadence: approval is a major de-risking event, but cash needs and ongoing losses remain an overhang until commercial ramp materializes .